Docusate Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

Docusate Sodium

Contract Pharmacy Services-PA

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate sodium 100 mg



Purpose

Stool softener

Uses

  • prevents/relieves dry hard stool
  • results usually occurs 1 to 3 days after the first dose

Warnings


Do not use

  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor

Ask a doctor before use if you

  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

  • you have no bowel movement after 3 days
  • you have rectal bleeding

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use.  

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not exceed recommended dose
adults and children over 12 years                        
take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years
take 1 softgel daily
children under 6 years
consult a doctor

Other information

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature 15o to 30oC (59o to 86oF)
  • protect from moisture

Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.


Questions?

Adverse drug event call: (866) 562-2756

Principal Display Panel

Principal Display Panel
Blister of 30

Docusate Sodium

Docusate Sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67046-140(NDC:16103-384)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
FD&C RED NO. 40
GELATIN
GLYCERIN
polyethylene glycol
propylene glycol
sorbitol

Product Characteristics

Color Size Imprint Code Shape
red (Two-toned- white and clear red) 5 mm 51A OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67046-140-30 30 in 1 BLISTER PACK
2 NDC:67046-140-60 60 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2007-01-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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